Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System

Trial details

Who runs it

Shockwave Medical, Inc.

Trial code

NCT05058456

Record updated

3 August 2026

Original description

Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.Read full original descriptionShow less

Prospective, Multi-center, Single-arm Feasibility Study of the Shockwave Medical Mini S Peripheral Intravascular Lithotripsy (IVL) System

Prospective, multi-center, single-arm feasibility study to assess the safety and performance of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.

Inclusion: -General Inclusion Criteria; Age of subject is ≥ 18 years; Subject is able and willing to comply with all assessments in the study; Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and has signed the approved consent form; Estimated life expectancy > 1 year; Rutherford Clinical Category 2, 3, 4 or 5 of the target limb(s); Angiographic Inclusion Criteria; One or two target lesion(s) located in a native de novo superficial femoral, popliteal or infrapopliteal artery (above the ankle joint), in one or both limbs; Target lesion reference vessel diameter (RVD) between 2.0 mm and 7.0 mm by investigator visual estimate; Target lesion stenosis ≥70% (for vessels below the knee defined as P3 to the ankle joint) or ≥90% (for vessels above the knee) by investigator visual estimate; Target lesion length is ≤150 mm by investigator visual estimate. Target lesion can be all or part of the 150 mm treated zone; Calcification is at least moderate defined as presence of fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending > 50% the length of the lesion if lesion is ≥50mm in length; or extending for minimum of 20mm if lesion is <50mm in length.

Exclusion: Subject in whom antiplatelet or anticoagulant therapy is contraindicated; Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated; Myocardial infarction within 60 days prior to enrollment; History of stroke within 60 days prior to enrollment; Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint; Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment; Failure to successfully treat significant non-target infra-popliteal lesions, if treated prior to target lesion(s). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism); History of endovascular or surgical procedure on the target limb within the last 30 days, or planned within 30 days of the index procedure. Note: inflow treatment of non-target lesions is allowed providing successful treatment; Subject has known allergy to urethane, nylon, or silicone; Covid-19 diagnosis within 30 days; Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries with ≤30% residual stenosis, and no serious angiographic complications (e.g. embolism); Failure to successfully cross the guidewire across the target lesion; successful crossing defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations; Subject has acute or chronic renal disease with eGFR <30 ml/min/1.73 m2 (using CKD-EPI formula), unless on renal replacement therapy; No calcium or mild calcium in the target lesion; General Exclusion Criteria; Rutherford Clinical Category 0, 1 and 6 (target limb); Subject is pregnant or nursing; Planned use of cutting/scoring balloons, re-entry or atherectomy devices in target lesion(s) during the index procedure; Planned major amputation of target limb; Acute limb ischemia; Occlusion of all the inframalleolar outflow arteries/vessels (i.e., desert foot); Subject already enrolled into this study; Angiographic Exclusion Criteria; Target lesion includes in-stent restenosis; Evidence of aneurysm or thrombus in target vessel; Target lesion within native or synthetic vessel grafts.

ClinicalTrials.gov NCT05058456